Pembrolizumab and XL888 in Patients With Advanced Gastrointestinal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03095781|
Recruitment Status : Recruiting
First Posted : March 30, 2017
Last Update Posted : April 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Adenocarcinoma Metastatic Pancreatic Adenocarcinoma Recurrent Colorectal Carcinoma Recurrent Pancreatic Carcinoma Stage III Colorectal Cancer Stage III Pancreatic Cancer Stage IIIA Colorectal Cancer Stage IIIB Colorectal Cancer Stage IV Colorectal Cancer Stage IV Pancreatic Cancer Stage IVA Colorectal Cancer Stage IVA Pancreatic Cancer Stage IVB Colorectal Cancer Stage IVB Pancreatic Cancer Unresectable Pancreatic Carcinoma||Drug: XL888 Biological: Pembrolizumab||Phase 1|
I. Determine the recommended phase II dose for the combination of XL888 and pembrolizumab.
I. Define the toxicity profile of the combination of XL888 and pembrolizumab.
II. Evaluate the activity of the combination of XL888 and pembrolizumab in previously treated patients with gastrointestinal tumors.
I. Evaluate the effect of the combination on the immune profile in the serum and in tumor biopsies.
OUTLINE: This is a dose-escalation study of Hsp90 inhibitor XL888.
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and XL888 orally (PO) on day 1, 4, 8, 11, 15, and 18. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and periodically thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib Trial of Pembrolizumab and XL888 in Patients With Advanced Gastrointestinal Malignancies|
|Actual Study Start Date :||June 28, 2017|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2023|
Experimental: Treatment (pembrolizumab, XL888)
Patients receive pembrolizumab IV over 30 minutes on day 1 and XL888 PO on days 1, 4, 8, 11, 15, and 18. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- Recommended phase II dose of the combination of XL888 and pembrolizumab as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Cycle length 21 days. Outcome determined on day 22 (after completion of cycle 1) ]Summary statistics will be presented. Toxicities will be presented as worst toxicity per patient and will be reported as percent toxicity.
- Overall response rate as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Up to 2 years after cycle 1, day 1. Cycle length is 21 days. ]RECIST version 1.1 will be used in this study for assessment of tumor response. While either CT or MRI may be utilized, as per RECIST 1.1, CT is the preferred imaging technique in this study.
- Overall survival [ Time Frame: Up to 1 year after cycle 1, day 1. Each cycle is 21 days. ]Once a subject experiences confirmed disease progression or starts a new anti-cancer therapy, the subject moves into the survival follow-up phase and should be contacted by telephone every 12 weeks to assess for survival status until death, withdrawal of consent, or the end of the study, whichever occurs first.
- Progression free survival [ Time Frame: Up to 6 months after cycle 1, day 1. Each cycle is 21 days ]Summary statistics will be presented.
- Response duration as assessed by RECIST 1.1 [ Time Frame: Up to 2 years after cycle 1, day 1. Each cycle is 21 days. ]Summary statistics will be presented.
- Immune profile effects of pembrolizumab and Hsp90 inhibitor XL888 assessed in serum and tumor biopsies [ Time Frame: Up to 2 years after cycle 1, day 1. Each cycle is 21 days. ]Summary statistics will be presented.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03095781
|Contact: Bassel El-Rayes, MDfirstname.lastname@example.org|
|United States, Georgia|
|Emory University Hospital Midtown||Recruiting|
|Atlanta, Georgia, United States, 30308|
|Contact: Shabnam Montazeri 404-686-0242 email@example.com|
|Contact: Swathi Chinaranagari 404-686-0239 firstname.lastname@example.org|
|Emory University/Winship Cancer Institute||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Sheena Abraham 404-778-2670 email@example.com|
|Emory Saint Joseph's Hospital||Recruiting|
|Atlanta, Georgia, United States, 30342|
|Contact: Alicia Escobar 678-843-7029 firstname.lastname@example.org|
|Contact: Krystal Reese 678-843-5911 email@example.com|
|Principal Investigator:||Bassel El-Rayes, MD||Emory University/Winship Cancer Institute|